Absken 2 mg film-coated tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

זמין מ:

Win Medica S.A. 1 - 3 Oidipodos & 33-35 Attiki Odos Turnoff 15238 Chaladri, Attica, , Greece

קוד ATC:

A06AX05

INN (שם בינלאומי):

PRUCALOPRIDE SUCCINATE 2 mg

טופס פרצבטיות:

FILM-COATED TABLET

הרכב:

PRUCALOPRIDE SUCCINATE 2 mg

סוג מרשם:

POM

איזור תרפויטי:

DRUGS FOR CONSTIPATION

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

מצב אישור:

Authorised

תאריך אישור:

2023-02-28

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ABSKEN 1 MG FILM-COATED TABLETS
ABSKEN 2 MG FILM-COATED TABLETS
prucalopride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Absken is and what it is used for
2.
What you need to know before you take Absken
3.
How to take Absken
4.
Possible side effects
5.
How to store Absken
6.
Contents of the pack and other information
1.
WHAT ABSKEN IS AND WHAT IT IS USED FOR
Absken contains the active substance prucalopride.
Absken belongs to a group of gut motility enhancing medicines
(gastrointestinal prokinetics). It acts
on
the muscle wall of the gut, helping to restore the normal functioning
of the bowel. Prucalopride is used
for the treatment of chronic constipation in adults in whom laxatives
do not work well enough.
Not for use in children and adolescents younger than 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABSKEN
DO NOT TAKE ABSKEN:
-
if you are allergic to prucalopride or any of the other ingredients of
this medicine (listed in section 6).
-
if you are on renal dialysis,
-
if you suffer from perforation or obstruction of the gut wall, severe
inflammation of the intestinal
tract, such as Crohn’s disease, ulcerative colitis or toxic
megacolon/megarectum.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Absken.
Take special care with Absken and tell your doctor if you:
-
suffer from severe kidney disease,
-
suffer from severe liver disease,
-
are currently under supervision by a doctor for a serious medical
problem such as lu

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Absken 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg prucalopride (as succinate).
Excipients with known effect. Each film-coated tablet contains 165.5
mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round biconvex, film-coated tablets debossed with “P2” on
one side and no debossing on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Absken is indicated for symptomatic treatment of chronic constipation
in adults in whom laxatives fail
to provide adequate relief.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
: 2 mg once daily with or without food, at any time of day.
Due to the specific mode of action of prucalopride (stimulation of
propulsive motility), exceeding the
daily dose of 2 mg is not expected to increase efficacy.
If the intake of once daily prucalopride is not effective after 4
weeks of treatment, the patient should
be re-examined and the benefit of continuing treatment reconsidered.
The efficacy of prucalopride has been established in double-blind,
placebo-controlled studies for up to
3 months. Efficacy beyond three months has not been demonstrated in
placebo-controlled studies (see
section 5.1). In case of prolonged treatment, the benefit should be
reassessed at regular intervals.
Special populations
_Older people (>65 years)_
: Start with 1 mg once daily (see section 5.2); if needed the dose can
be
increased to 2 mg once daily.
_Patients with renal impairment_
: The dose for patients with severe renal impairment
(GFR < 30 ml/min/1.73 m
2
) is 1 mg once daily (see sections 4.3 and 5.2). No dose adjustment is
required for patients with mild to moderate renal impairment.
_Patients with hepatic impairment_
: Patients with severe hepatic impairment (Child-Pugh class C) start
with 1 mg once daily which may be increased to 2 mg if required to
improve effi